Tata Consultancy Services has launched an agile and intuitive risk-based monitoring solution for clinical trials, that enables intelligent decision making, increased compliance and improves study efficacy.
Part of the TCS ADD™ suite, the new risk-based monitoring solution enables biopharmaceutical and Contract Research Organizations (CROs) to identify study and site risks through advanced statistical algorithms and drive intelligent data driven decisions. The data science led risk-based monitoring solution precisely predicts outcomes pertaining to site workload and risks, thereby enabling stakeholders to lay out proactive monitoring strategies.
The risk-based monitoring solution comprises:
- Intelligent risk management that facilitates automated triggers for outliers with advanced analytics and visualizations.
- AI/ML based predictive analytics with leading indicators of site monitoring workload analytics.
- 40+ operational metrics across study, site, subject, data management and budget management categories, providing a holistic performance view across site, country, region, study, program, compound and therapeutic area.
- A one-click communication module that provides a unified and collated list of pending activities, and system generated intelligent actions across all source systems; driving greater engagement and collaboration.
The novel and intuitive Risk Based Monitoring solution provides insights into missing data, improving data quality and consistency, and enabling early identification of trends and outliers. Sponsors and CROs are expected to realize up to 30% efficiency gain in site monitoring through the solution. In addition, automation speeds up the process, reduces site workload, improves overall compliance, and contributes to product speed-to-market.
“With COVID 19 critically impacting site visits, life sciences industries realized the value of remote Risk Based Monitoring solutions that empower sponsors to monitor trials centrally, assess the risks and track corrective actions to enhance study quality,” said Debashis Ghosh, Business Group Head, Life Sciences Healthcare, and Public Services, TCS. “With our deep domain knowledge of the life sciences industry, we are continually expanding the capabilities of our modern and open TCS ADD platform to include data science, artificial intelligence and machine learning led clinical operational analytics solutions that transform the drug development value chain, deliver greater value for our customers and achieve faster compliance.”